Plant stanols and derivatives thereof (e.g., phytosterols and esters thereof) are known to possess health enhancing properties including imparting positive cholesterol effects such as reducing or lowering blood cholesterol levels. These compounds are generally referred to hereinafter as stanol compounds. Such naturally occurring products have a chemical structure similar to that of cholesterol. They are considered essential constituents for properly functioning cells. Stanol compounds are typically C26-C30 alcohols which have an aliphatic chain in the C-17 position. Stanol compounds are believed to reduce cholesterol by binding to cholesterol and thereby forming a complex, which is readily passed out of the body. Since high blood cholesterol levels have consistently been implicated as an important risk factor in cardiac and vascular diseases, the reduction of blood cholesterol is seen as a means of helping to prevent and/or reduce the effects of cardiac and vascular disease.
Stanol compounds have been combined with various food products to provide a convenient means of administering the active agent to humans. For example, there are currently two commercially available margarine based products known as Benecol (a trademark of Raisio Benecol Ltd, of Rasio Finland) and Take Control (a trademark of Lipton Company of Englewood Cliffs, N.J.), each of which contains a stanol compound. The stanol compound containing margarine is applied and used in a manner similar to conventional margarine products.
Other stanol compound-containing products are described, for example, in U.S. Pat. No. 5,591,836, which discloses the use of saponins bonded to sterols through a glycosidic linkage. The resulting complexes are used in a variety of products such as tablets, capsules, granules, cookies, wafers, candy products and the like for the purpose of reducing blood cholesterol levels.
WO99/15546 discloses the use of sistosterols as a dietary supplement in such food products as mustards, salad dressings, peanut butter, light spreads including margarine and mayonnaise as well as chocolate-flavored mint truffles.
WO98/58554 discloses the employment of a premix containing pulverized plant sterols and a conventional foodstuff raw material to prepare bakery products including bread, cake, pastries, crackers, biscuits, and the like.
European Patent Application No. 089767181 discloses the preparation of an aqueous dispersion of plant sterols and other high microlipids for use in spreads and other food products including beverages, dairy products, dry mixers, powdered non-dairy products, coffee, whiteners, milk shake mixes, confections, ice creams, instant milks, cake mixes, and the like.
Phytosterols have also been added to beverage compositions and acetic acid compositions such as disclosed in WO99/15547.
As indicated above, the incorporation of stanol compounds in wide variety of food products is known in the art. In many cases, the stanol compound is recognized as a cholesterol reducing agent. However, in order to obtain a cholesterol reducing effect in a human, the food product must be ingested in large quantities to provide a sufficient amount of the stanol compound to accomplish this purpose.
From a practical standpoint, the prior art food products contain r latively low levels of stanol compounds and therefore require the ingestion of large amounts of the food product to provide a sufficient amount of the stanol compounds in order to obtain a desired cholesterol reducing effect.
One particular class of food products incorporated with stanol compounds is chewing gum. The above problems encountered in the prior art are especially manifested in chewing gums. Stanol compounds especially plant stanols are oil soluble compounds, and they have a remarkably high affinity for the gum base employed in the making of chewing gum products. As a result, only a small portion of the stanol compound present in the chewing gum is released during chewing, while the rest of the stanol compound remains trapped in the gum base and unavailable to provide a positive cholesterol effect.
There are two major disadvantages of such chewing gums. First, the amount of the chewing gum, which must be chewed, is typically higher than the amount a consumer would consider convenient. Second, the chewing gum must be administered at least several times a day because individually the chewing gums are not able to deliver or do not contain sufficient stanol compounds to obtain a meaningful cholesterol reducing effect. Under these circumstances, the typical consumer is not likely to follow a regimen which requires ingestion of several and up to many individual servings of a chewing gum composition in order to obtain a cholesterol reducing effect. Such regimens have been problematical because they require discipline, and are contrary to acceptable chewing gum regimens for most humans.
To overcome this problem, it is theoretically possible to add higher amounts of stanol compounds per piece of chewing gum. However, high dosing of plant stanol compound adds significantly to the cost of producing such chewing gums, and may adversely affect the organoleptic and taste properties of the chewing gum.
A key to obtaining a positive cholesterol effect from chewing gums containing stanol compounds is to provide a chewing gum product which can deliver a desirable amount of the stanol compound in a small number of individual servings, preferably only one or two servings.
It would therefore be a significant advance in the art of reducing cholesterol if a chewing gum containing stanol compounds could be developed which contains a sufficient amount of stanol compounds that can be released at a suitable rate to furnish an effective positive cholesterol effect to aid in the overall nutritional regimen of the consumer.
It would be a further advance in the art if a chewing gum composition could be produced which can reduce cholesterol levels in a human in need of a reduction in cholesterol levels and can be readily adapted to a consumer's daily regimen over an extended period of time.
It would be a still further advance in the art if a chewing gum composition could be developed which is effective in providing a positive cholesterol effect but does not require the consumer to chew large volumes of a chewing gum product.